FDA.reportPublic FDA data

MAUDE MDR 9501113

MDR report key
9501113
Report number
3005031160-2019-00051
Event key
0
Event type
3
Date of event
2019-11-22
Date received
2019-12-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. CASEY MING
Address
664 CRUISER LANE BELGRADE MT 59714 US
Phone
406-406-4063
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CERTEX SPINAL FIXATION SYSTEMSPINAL IMPLANTSX-SPINE SYSTEMS, INC.HWXX067-04664640R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-12-2001. O

Event Narratives#

N

Patient 1

THE COMPLAINANT REPORTED THAT FOLLOWING USE OF A TAP, IT WAS IDENTIFIED THAT THE TAP WAS BROKEN. THE BROKEN PORTION OF THE TAP WAS RECOVERED AND THERE WAS AN ADDITIONAL TAP AVAILABLE TO COMPLETE THE SURGERY. THERE WERE NO REPORTED PATIENT COMPLICATIONS. THE COMPLAINT DEVICE WAS NOT RETURNED FOR COMPLAINT ASSESSMENT, IT WAS DISCARDED AT THE HOSPITAL. VISUAL AND FUNCTIONAL ASSESSMENTS COULD NOT BE PERFORMED. A DHR REVIEW WAS PERFORMED FOR LOT# 4640 AND THERE WERE NO MANUFACTURING ANOMALIES IDENTIFIED. THE DEVICE MET ALL REQUIRED SPECIFICATIONS PRIOR TO BEING INITIALLY RELEASED ON 11/11/2013. IT MAY BE POSSIBLE THAT THE TAP COULD BREAK IF THE TAP OR ASSOCIATED TAP GUIDE WAS INADVERTENTLY SHIFTED WHILE IN USE. IF THE TAP OR TAP GUIDE WAS SHIFTED LATERALLY WHILE IN USE, IT COULD CONCENTRATE APPLIED FORCE TO THE PORTION OF THE TAP SHAFT WITH MINIMAL MATERIAL, RESULTING IN AN INSTRUMENT MALFUNCTION.

D

Patient 1

THE COMPLAINANT REPORTED THAT FOLLOWING USE OF A TAP, IT WAS IDENTIFIED THAT THE TAP WAS BROKEN. THE BROKEN PORTION OF THE TAP WAS RECOVERED AND THERE WAS AN ADDITIONAL TAP AVAILABLE TO COMPLETE THE SURGERY. THERE WERE NO REPORTED PATIENT COMPLICATIONS.